ID
25762
Descripción
Study ID: 101468/207 Clinical Study ID: SKF-101468/207 Study Title:A double-blind, randomized, placebo-controlled, parallel-group study to investigate the tolerability of a dose-escalating regimen of ropinirole in patients suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication : Restless Legs Syndrome AE Section
Palabras clave
Versiones (1)
- 18/9/17 18/9/17 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
18 de septiembre de 2017
DOI
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Licencia
Creative Commons BY-NC-ND 3.0
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AE Section GSK Ropinirole Restless Legs Syndrome 101468
AE Section GSK Ropinirole Restless Legs Syndrome 101468
- StudyEvent: ODM
Descripción
Adverse Event - Please note any SERIOUS events should NOT be recorded on this page, but on the SERIOUS ADVERSE EVENT pages provided. Record any Adverse event (using standard medical terminology) observed or elicited as a result of spontaneous reporting by patient 'How are you feeling' (pre-dose) and at subsequent schedules intervals post dose: 'Since you were last asked have you felt unwell or different from usual?'
Alias
- UMLS CUI-1
- C0877248
Descripción
Adverse Event
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0877248
Descripción
Adverse Event: Specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2348235
Descripción
Onset Date
Tipo de datos
date
Unidades de medida
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C0574845
Descripción
Onset Time
Tipo de datos
time
Unidades de medida
- 24hr:min
Alias
- UMLS CUI [1]
- C0449244
Descripción
End Date
Tipo de datos
date
Unidades de medida
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C0806020
Descripción
End Time
Tipo de datos
time
Unidades de medida
- 24hr:min
Alias
- UMLS CUI [1]
- C1522314
Descripción
Adverse Event Outcome
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1705586
Descripción
Event Course
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Descripción
Number of Episodes
Tipo de datos
float
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4086638
Descripción
Intensity
Tipo de datos
text
Descripción
Action Taken
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826626
Descripción
Relationship
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0439849
Descripción
Corrective Therapy
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Descripción
Withdrawal due to Adverse Event
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Descripción
Adverse Event Date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2697888
Similar models
AE Section GSK Ropinirole Restless Legs Syndrome 101468
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])